CASP for case control studies

https://casp-uk.net/checklists/casp-case-control-study-checklist-fillable.pdf

1. Did the study address a clearly focused issue?

HINT: An issue can be ‘focused’ in terms of the population studied, whether the study tried to detect a beneficial or harmful effect, and the risk factors studied.

2. Did the authors use an appropriate method to answer their question?

HINT: Consider whether a case control study is an appropriate way of answering the question under the circumstances and whether it addresses the study question.

3. Were the cases recruited in an acceptable way?

HINT: Look for selection bias which might compromise the validity of the findings, such as whether the cases were defined precisely, representative of a defined population, selected through an established reliable system, incident or prevalent, and whether there was a sufficient number of cases selected.

4. Were the controls selected in an acceptable way?

HINT: Look for selection bias which might compromise the generalisability of the findings, such as whether the controls were representative of the defined population, matched, population-based or randomly selected, and whether there was a sufficient number of controls selected.

5. Was the exposure accurately measured to minimise bias?

HINT: Look for measurement, recall or classification bias, such as whether the exposure was clearly defined and accurately measured, whether subjective or objective measurements were used, and whether the measurement methods were similar in the cases and controls.

6. (a) Aside from the experimental intervention, were the groups treated equally?

HINT: List the ones you think might be important that the author may have missed, such as genetic, environmental, and socio-economic factors.

6. (b) Have the authors taken account of the potential confounding factors in the design and/or in their analysis?

HINT: Look for techniques such as restriction in design, and techniques such as modelling, stratified-, regression-, or sensitivity analysis to correct, control or adjust for confounding factors.

7. How large was the treatment effect?

HINT: Consider what the bottom line results are, whether the analysis is appropriate to the design, and how strong the association is between exposure and outcome.

8. How precise was the estimate of the treatment effect?

HINT: Consider the size of the p-value, size of the confidence intervals, and whether the authors considered all the important variables.

9. Do you believe the results?

HINT: Consider whether the results can be due to chance, bias, or confounding, whether the design and methods of the study are sufficiently flawed to make the results unreliable, and whether the results fit with other available evidence.

10. Can the results be applied to the local population?

HINT: Consider whether the subjects covered in the study could be sufficiently different from your population to cause concern, whether your local setting is likely to differ much from that of the study, and whether you can quantify the local benefits and harms.

11. Do the results of this study fit with other available evidence?

HINT: Consider all the available evidence from RCTs, systematic reviews, cohort studies, and case control studies for consistency.

STROBE

 1. Title and Abstract

   - Indicate the study's design with a commonly used term in the title or the abstract.

   - Provide a structured summary of study design, methods, results, and conclusions.

2. Introduction

   - Explain the scientific background and rationale for the investigation.

   - State specific objectives, including any pre-specified hypotheses.

3. Methods

   - Present key elements of study design early in the paper.

   - Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection.

   - Clearly define eligibility criteria, and the sources and methods of selection of participants.

   - Clearly define the outcomes, any exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable.

   - Describe the methods of assessment for each variable or a reference if it's a standard method.

   - Describe any efforts to address potential sources of bias.

   - Explain how quantitative variables were handled in the analyses.

   - Describe all statistical methods, including those used to control for confounding.

   - Describe any sensitivity analyses.

4. Results

   - Report the numbers of individuals at each stage of the study.

   - Give reasons for non-participation at each stage.

   - Consider use of a flow diagram.

   - Provide a descriptive analysis of the data.

   - Report outcome data and a summary of the main findings.

   - Give estimates of the random variability for important outcomes.

   - Report all important adverse events or side effects.

5. Discussion

   - Summarize key results with reference to study objectives.

   - Discuss limitations of the study, taking into account sources of potential bias or imprecision.

   - Discuss the generalizability (external validity) of the study results.

6. Other Information

   - If relevant, describe funding sources and the role of funders for the present study.

   - Indicate if there were any pre-specified analyses.

ROBINS-I

1. Bias due to Confounding

   - Were confounding variables measured and adjusted for in the analysis?

   - Were the strategies to control for confounding appropriate and effective?

2. Bias in Selection of Participants into the Study

   - How were participants selected?

   - Were there differences in the groups being compared that could affect the outcomes?

3. Bias in Classification of Interventions

   - How was the intervention classified or defined?

   - Was there potential misclassification of the intervention status?

4. Bias due to Deviations from Intended Interventions

   - Were there deviations from the intended intervention?

   - How were these deviations managed in the study analysis?

5. Bias due to Missing Data

   - How much data were missing for each variable?

   - Were missing data handled appropriately in the analysis?

6. Bias in Measurement of Outcomes

   - Were the methods of measuring outcomes consistent across groups?

   - Is there evidence that the measurement of the outcome was influenced by knowledge of the intervention received?

7. Bias in Selection of the Reported Result

   - Were the reported results pre-specified or exploratory?

   - Are there concerns that the reported analyses were selected based on the results?

ROB 2

# https://methods.cochrane.org/risk-bias-2

# https://www.bmj.com/content/366/bmj.l4898

# [Risk-of-bias assessment using Cochrane's revised tool for randomized trials (RoB 2) was useful but challenging and resource-intensive: observations from a systematic review 23](https://www.sciencedirect.com/science/article/pii/S0895435623001634)

1.1 Was the allocation sequence random?

1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?

1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?

2.1. Were participants aware of their assigned intervention during the trial?

2.2. Were carers and people delivering the interventions aware of participants' assigned

intervention during the trial?

2.3. Were important non-protocol interventions balanced across intervention groups?

2.4. Were there failures in implementing the intervention that could have affected the outcome?

2.5. Was there non-adherence to the assigned intervention regimen that could have affected participants' outcomes?

2.6. Was an appropriate analysis used to estimate the effect of adhering to intervention?

3.1 Were data for this outcome available for all, or nearly all, participants randomized?

3.2 Is there evidence that the result was not biased by missing outcome data?

3.3 Could missingness in the outcome depend on its true value?

3.4 Is it likely that missingness

in the outcome depended on its true value?

4.1 Was the method of measuring the outcome inappropriate?

4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?

4.3 Were outcome assessors aware of the intervention received by study participants?

4.4 Could assessment of the outcome have been influenced by knowledge of intervention received?

4.5 Is it likely that assessment of the outcome was influenced by knowledge of intervention received?

5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?

5.2.... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?

5.3... multiple eligible analyses of the data?

CONSORT 2010

 1. Title and Abstract:

   - Identification as a randomized trial in the title.

   - Structured summary of trial design, methods, results, and conclusions.

2. Introduction - Background and Objectives:

   - Scientific background and explanation of rationale.

   - Specific objectives or hypotheses.

3. Methods - Trial Design:

   - Description of trial design (such as parallel, factorial) including allocation ratio.

4. Methods - Changes to Trial Design:

   - Changes to trial design after the trial commenced, with reasons.

5. Methods - Eligibility Criteria for Participants:

   - Eligibility criteria for participants and the settings and locations where the data were collected.

6. Methods - Interventions:

   - The interventions for each group with sufficient details to allow replication, including how and when they were actually administered.

7. Methods - Outcomes:

   - Clearly defined primary and secondary outcome measures and, when applicable, any changes after trial commencement, with reasons.

8. Methods - Participant Timeline:

   - Participant timeline (e.g., periods of recruitment, follow-up, and data collection).

9. Methods - Sample Size:

   - How sample size was determined and, when applicable, explanation of any interim analyses and stopping guidelines.

10. Methods - Randomization: Sequence Generation:

   - Method used to generate the random allocation sequence.

11. Methods - Randomization: Type:

   - Type of randomization; details of any restriction (e.g., blocking, stratification).

12. Methods - Randomization: Implementation:

   - Mechanism used to implement the random allocation sequence, ensuring that the sequence was concealed until participants were enrolled and assigned; who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions.

13. Methods - Blinding:

   - Whether participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment; if done, how the success of blinding was evaluated.

14. Methods - Statistical Methods:

   - Statistical methods used to compare groups for primary outcomes; methods for additional analyses, such as subgroup analyses.

15. Results - Participant Flow:

   - Flow of participants through each stage of the trial (diagram recommended), including numbers of participants randomly assigned, receiving intended treatment, completing the trial protocol, and analyzed for the primary outcome.

16. Results - Recruitment:

   - Dates defining the periods of recruitment and follow-up.

17. Results - Baseline Data:

   - Baseline demographic and clinical characteristics of each group.

18. Results - Numbers Analyzed:

   - Number of participants in each group included in each analysis and whether the analysis was by original assigned groups.

19. Results - Outcomes and Estimation:

   - For each primary and secondary outcome, results for each group, and the estimated effect size and its precision.

20. Results - Ancillary Analyses:

   - Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory.

21. Results - Harms:

   - All important harms or unintended effects in each group.

22. Discussion - Limitations:

   - Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses.

23. Discussion - Generalizability:

   - Generalizability (external validity) of the trial findings.

24. Discussion - Interpretation:

   - Interpretation consistent with results, balancing risks and benefits, and considering other relevant evidence.

25. Other Information - Registration:

   - Registration number and name of the trial registry.

26. Other Information - Protocol:

   - Where the full trial protocol can be accessed, if available.

27. Other Information - Funding:

   - Sources of funding and other support (such as supply of drugs), role of funders.

CASP checklists for cohort study

https://casp-uk.net/casp-tools-checklists/

1. Did the study address a clearly focused issue?

2. Was the cohort recruited in an acceptable way?

3. Was the exposure accurately measured to minimize bias?

4. Was the outcome accurately measured to minimize bias?

5. Have the authors identified all important confounding factors?

6. Have they taken account of the confounding factors in the design and/or analysis?

7. Was the follow up of subjects complete enough?

8. How precise are the results?

9. Do you believe the results?

10. Can the results be applied to the local population?

11. Do the results of this study fit with other available evidence?

12. What are the implications of the study for practice?

CASP checklists for RCT

https://casp-uk.net/casp-tools-checklists/

https://casp-uk.net/

1. Did the study address a clearly focused research question?

CONSIDER:

Was the study designed to assess the outcomes of an intervention?

Is the research question 'focused' in terms of: Population studied, Intervention given, Comparator chosen, Outcomes measured?

2. Was the assignment of participants to interventions randomised?

CONSIDER:

How was randomisation carried out? Was the method appropriate?

Was randomisation sufficient to eliminate systematic bias?

Was the allocation sequence concealed from investigators and participants?

3. Were all participants who entered the study accounted for at its conclusion?

CONSIDER:

Were losses to follow-up and exclusions after randomisation accounted for?

Were participants analysed in the study groups to which they were randomised

(intention-to-treat analysis)?

Was the study stopped early? If so, what was the reason?

4. Were the participants 'blind' to intervention they were given?

Were the investigators 'blind' to the intervention they were giving to participants?

Were the people assessing/analysing outcome/s 'blinded'?

5. Were the study groups similar at the start of the randomised controlled trial?

CONSIDER:

Were the baseline characteristics of each study group (e.g. age, sex, socio-economic group) clearly set out?

Were there any differences between the study groups that could affect the outcome/s?

6. Apart from the experimental intervention, did each study group receive the same level of

care (that is, were they treated equally)?

CONSIDER:

Was there a clearly defined study protocol?

If any additional interventions were given

(e.g. tests or treatments), were they similar between the study groups?

Were the follow-up intervals the same for each study group?

7. Were the effects of intervention reported comprehensively?

CONSIDER:

Was a power calculation undertaken?

What outcomes were measured, and were they clearly specified?

How were the results expressed? For binary outcomes, were relative and absolute effects reported?

Were the results reported for each outcome in each study group at each follow-up interval?

Was there any missing or incomplete data?

Was there differential drop-out between the study groups that could affect the results?

Were potential sources of bias identified?

Which statistical tests were used?

Were p values reported?

8. Was the precision of the estimate of the intervention or treatment effect reported?

CONSIDER:

Were confidence intervals (CIs) reported?

9. Do the benefits of the experimental intervention outweigh the harms and costs?

CONSIDER:

What was the size of the intervention or treatment effect?

Were harms or unintended effects reported for each study group?

Was a cost-effectiveness analysis undertaken? (Cost-effectiveness analysis allows a comparison to be made between different interventions used in the care of the same condition or problem.)

10. Can the results be applied to your local population/in your context?

CONSIDER:

Are the study participants similar to the people in your care?

Would any differences between your population and the study participants alter the outcomes reported in the study?

Are the outcomes important to your population?

Are there any outcomes you would have wanted information on that have not been studied or reported?

Are there any limitations of the study that would affect your decision?

11. Would the experimental intervention provide greater value to the people in your care than

any of the existing interventions?

CONSIDER:

What resources are needed to introduce this intervention taking into account time, finances, and skills development or training needs?

Are you able to disinvest resources in one or more existing interventions in order to be able to re-invest in the new intervention?